DE102008059547B4 - Device for removing concretions in body vessels - Google Patents

Abstract

Device for removing calculus from body vessels with at least one compressible receiving element (20) for receiving calculus and a supply device (10) for guiding the compressed receiving element (20), wherein the receiving element (20) has a fluid-tight cover (21) which has a forms a cavity (30a) that can be closed by the concrement to be removed, in particular a proximal cavity (30a), wherein the receiving element (20) is assigned an actuating device (11) which, at least when in use, is in operative connection with the cover (21) and/or the cavity (30a). such that a different pressure can be set in the cavity (30a) for moving, in particular for loosening, the calculus to be removed than outside the cavity (30a), characterized in that the actuating device (11) comprises a suction and/or pressure device, which is or can be fluidly connected to the cavity (30a) by a pressure line (15), wherein the pressure line (1 5) is formed by the feed device (10) itself.

Description

The invention relates to a device for removing calculus from body vessels according to the preamble of claim 1. Such a device is known, for example, from WO 2006/031 410 A2.

The formation of calculus in body vessels can result in the body vessel being completely or at least partially occluded by the calculus, with the consequence of significant health restrictions. A particularly high risk is posed by thrombi, i.e. blood clots that form intravascularly and can partially or completely occlude the blood vessel. When the occlusion affects an artery, the tissues downstream become deprived or insufficiently supplied with oxygen and other nutrients, a condition known as ischemia, which can result in tissue death.

At present, thrombi in human arteries are usually treated by drug thrombolysis, in which blood clots are dissolved with the help of drugs. The prerequisite for this therapy is that the treatment takes place no later than three hours after the onset of the symptoms. In addition to this narrow time window, drug thrombolysis has the disadvantage that the treatment not only acts locally in the area of the thrombus, but also in other areas, for example in nearby areas of the brain. By inhibiting blood clotting, there is a risk of bleeding complications, in particular the risk that the therapy will trigger cerebral hemorrhage.

An alternative to drug therapy is the mechanical removal of thrombi from blood vessels, in which, for example, a device according to WO 2006/031 410 A2 mentioned at the outset is used. The known device comprises a holding basket with a stent-like lattice structure, which is arranged in a compressed state within a catheter for introduction into the blood vessel. To remove the blood clot, the catheter is inserted into the blood vessel until the tip of the catheter is positioned near the thrombus. The holding basket arranged in the catheter is released at the tip of the catheter and unfolds there to about the size of the blood vessel, so that the thrombus can be picked up by the basket. The catheter is also designed as an aspiration catheter, which creates negative pressure in the area in front of the thrombus so that parts of the thrombus are detached and sucked into the catheter. The receiving basket also serves as a filter, so that no larger particles are transported past the aspiration catheter into other blood vessels.

In the known device, negative pressure is applied to a relatively large area in the area in front of the thrombus as a result of the aspiration. The pressure in a larger area of the brain falls below the physiological pressure and there is a risk that the transmural pressure will become negative. This can result in the blood vessel in front of the thrombus becoming narrowed or collapsing, so that the blood flow in this area is restricted or comes to a complete standstill. On the one hand, this prevents efficient detachment of the thrombus and, on the other hand, there is a risk that the vessel will be injured by the effect of the negative transmural pressure. In particular, if the negative pressure is effective in vascular areas with branching accessory vessels, there is a risk that the accessory vessels will collapse and tissue areas that have previously had a good blood supply will therefore be undersupplied. Even with positive transmural pressure, aspiration-induced negative pressure, i.e., pressure less than physiological pressure, leads to decreased blood flow to the affected areas, particularly in the brain.

A further problem with the use of the known device arises in cases when the thrombus to be released does not occlude the entire cross-section of the vessel, so that blood flow is still partially possible. Such a situation can arise, for example, if parts of the thrombus have already been removed by the aspiration, so that the vessel is partially recanalized, i.e. reopened. There is a risk that the blood now flowing past the catheter and through the receiving basket will entrain particles when passing through the thrombus, which can lead to renewed occlusion in smaller blood vessels further downstream. In order to counteract this process, it is known to increase the aspiration volume so that all of the blood flowing through the blood vessel is aspirated. In this case, a large amount of the blood volume is removed from the patient in a relatively short period of time, which can result in significant health consequences for the patient.

Particle detachment with subsequent occlusion of vessels located downstream can occur above all if a relatively large particle is detached from the thrombus by aspiration, sucked in by the catheter and the suction opening thereby closed. The generation of the negative pressure is suddenly interrupted so that the original pressure conditions in the blood vessel are restored. The blood flow that develops again can further Particles detach and are transported into downstream vessels, which can lead to renewed vascular occlusion.

U.S. 6,632,236 B2 describes a catheter for removing emboli from arteries. The catheter has an automatically expandable tip and can be connected to a venous catheter via a connecting line in order to achieve a continuous blood flow through the catheter through a pressure difference between a treatment chamber distal to the expanded tip and the vein in which the venous catheter is positioned. This catheter system is difficult to handle in practice and has a limited scope of use. In particular, the known catheter can only be used to remove emboli in arteries. Thrombi in veins cannot be treated with it. In addition, to feed in the known catheter, a feed hose is required that is slit over its entire length so that it is not impeded by a side port of the catheter when it is pulled back. Such feed hoses are not very stable and thus prevent the use of the catheter in small, heavily curved sections of blood vessels.

U.S. 5,011,488 A describes a catheter that includes an expandable tip and itself forms a conduit for creating a vacuum. The catheter also requires a feed tube that has no other function beyond the feed function. A similar catheter disclosed WO 2006/019728 A2 .

Out of DE 601 28 207 T2 a balloon catheter is known whose balloon can be withdrawn when inflated. This is intended to create a pressure difference that draws particles into the catheter. However, the mechanical movement of the balloon can lead to undesirable irritation of the vessel walls.

The invention is based on the object of specifying a device for removing calculus from body vessels that ensures simple and safe handling and functioning and reduces the health risks for the patient.

According to the invention, this object is achieved by the subject matter of claim 1. Alternatively, this object is achieved by the subject matter of patent claim 17.

The invention is based on the idea of specifying a device for removing calculus from body vessels with at least one compressible receiving element for receiving calculus and a supply device for guiding the compressed receiving element, the receiving element having a fluid-tight cover which can be closed by the calculus to be removed , in particular a proximal cavity, wherein the receiving element is assigned an actuating device which, at least when in use, is operatively connected to the cover and/or the cavity in such a way that a different pressure can be set in the cavity for moving, in particular for loosening, the calculus to be removed than outside the cavity, particularly on the distal side of the calculus to be removed.

The invention has the advantage that the calculus is sucked into the cavity or the receiving element by setting a lower pressure in the cavity than the physiological pressure (negative pressure) or is pushed into the cavity by the higher physiological pressure acting on the calculus. In this respect, a force acting in the direction of the receiving element (caused by the pressure difference on both sides of the calculus) is generated on the calculus to be removed by the actuating device. It is also possible for the pressure gradient to be reversed at least temporarily in such a way that an overpressure, i.e. a higher pressure than the physiological pressure, is generated in the cavity, so that the calculus is briefly subjected to a force acting in the distal direction in order to loosen it. In order to suck the calculus into the receiving element, a negative pressure is again set in the cavity.

To form the cavity, the receiving element delimits a space that is open in the axial direction, in particular in the distal axial direction, and which can be closed during use by the calculus to be removed. The delimitation of the space or cavity in the other axial direction, in particular in the proximal axial direction, is effected by the fluid-tight cover. The fluid-tight cover is adapted or extends so far in the distal direction of the receiving element that the cover closes fluid-tight with the vessel wall during use. As a result, the vessel is sealed in one direction, in particular in the proximal direction. The sealing in the other direction, in particular in the distal direction, is taken over by the calculus that lies against the vessel wall and closes the vessel.

For the cavity to be closed by the calculus, it is not necessary for the calculus to be in direct contact with the sealed receiving element. It is sufficient if the cross-section of the vessel section downstream of the receiving element and thus the cross-sectional area of the distal opening of the receiving element are of concrete ment is covered, the calculus can be arranged slightly spaced from the receiving element. A hermetic vascular closure by the calculus is not required to build up the pressure drop between the distal and the proximal side of the calculus. It is sufficient if the amount of blood that may flow through the calculus is so small that a time-delayed pressure equalization occurs.

In this case, cavities within the meaning of the application are generally spaces which are formed by interaction of the calculus to be removed with the receiving element or the fluid-tight cover and which are essentially free of built-in components and sealed in a fluid-tight manner. In this way, the cavity can form a receiving function for the calculus and/or a sealed area in which a pressure that is different from the environment can be set. There can be liquid, in particular blood, in the cavity.

Furthermore, within the scope of the present application, the term pressure is understood not only to mean positive pressures (overpressure), but also explicitly to mean negative pressures (underpressure). An overpressure is a pressure which is higher than the pressure prevailing in the vessel. Accordingly, a negative pressure is a pressure that is lower than the pressure prevailing in the vessel. In the case of the possible collapse of the vessel that occurs in the prior art, the negative pressure is so pronounced that the transmural pressure becomes negative.

The invention is particularly suitable for removing clots or thrombi from blood vessels. Although the invention is described below using the example of the removal of thrombi, other possible uses of the device, which relate to the removal of concretions or objects from body cavities, are also covered by the invention.

The spatial designations or directional information, in particular the designations distal and proximal, relate to the position of the user, in particular the doctor operating the device. Accordingly, objects arranged distally are arranged further away from the user or operator of the device with respect to an object arranged proximally.

The invention has the advantage that, during use, the generation of pressure in front of the calculus is locally limited by the fluid-tight cover, i.e. the pressure only acts in the area of the cavity, in particular the proximal cavity. In order to move the calculus or thrombus into the receiving element, the cavity is preferably subjected to negative pressure, i.e. a pressure which is lower than the blood pressure behind the thrombus, although it is not excluded that the pressure inside the cavity may also be greater, at least temporarily can be considered outside the cavity (overpressure). At the same time, the vessel wall is supported by the receiving element expanded in the vessel, so that a vessel collapse is avoided or prevented. Furthermore, the closed, in particular proximally arranged cavity ensures that when the pressure is generated by fluid displacement, only the volume that is necessary for moving the thrombus into the receiving element is supplied or removed. The removal of a relatively large volume of blood is thus avoided. Outside the cavity, in particular proximal to the cavity, the blood pressure is not reduced, so that vascular collapse and a possible undersupply of brain areas are prevented.

The fluid-tight cover of the receiving element essentially separates the thrombus from the blood flow, i.e. there is essentially no flow in the cavity, in particular the proximal cavity. This avoids high shear stresses acting on the thrombus due to the pressure generation in the cavity, which can lead to the detachment of individual thrombus particles. Rather, the pressure generated in the cavity causes the thrombus to be completely loosened and moved into the receiving element, since the same pressure gradient acts on the entire cross-sectional area of the thrombus and the thrombus thus slides homogeneously into the receiving element.

Overall, the invention makes use of the inherently negative effect of a vascular occlusion by using the occlusion in conjunction with the device according to the invention to create a cavity in the vascular that can be subjected to pressure or negative pressure and serves to release the occlusion and to remove the locking body. The receiving element corresponds in its function to a suction cup, i.e. the receiving element is designed in the manner of a suction cup.

In the device according to the invention, the actuating device comprises a suction and/or pressure device which is or can be fluidly connected to the cavity. The suction and/or pressure device preferably comprises a pressure generation unit which is or can be fluidly connected to the cavity by a pressure line, the pressure line being formed according to the invention by the supply device itself. With the suction and/or pressure device, in particular with the pressure generating unit, the pressure within the cavity, in particular of the Proximal cavity can be changed particularly easily compared to the pressure outside the proximal cavity, for example by supplying and / or removing liquid or other fluids.

In this context, it is pointed out that the term fluids in the context of the present application not only refers to liquids, but also to gases.

The actuating device preferably comprises an actuating medium, in particular a liquid, which can be pumped at least partially into the cavity, in particular the cavity arranged proximally, and/or can be sucked out of the cavity. With the actuating medium, the generation of pressure in the cavity can be easily controlled by a user from outside the body. It is also conceivable that the actuating medium includes mechanical components.

Further structural features of the invention are described below, with the description relating to the device in use or in the expanded state of the receiving element.

The receiving element can be designed like a basket. The receiving element can also have a distal, essentially cylindrical section which includes an opening for receiving a calculus. The section of the basket-like receiving element that forms the opening can also have a different contour. During use, the cylindrical section, which can be designed essentially like a stent, rests against the vessel wall, which ensures sufficient space and stability to accommodate the blood clot or thrombus on the one hand and to stabilize the blood vessel on the other hand in such a way that the pressure generated in the lumen does not result in collapse of the blood vessel. The opening for receiving the thrombus is preferably arranged at the distal end of the receiving element and has approximately the diameter of the blood vessel, so that the blood clot can be received in one piece. It is possible for the cylindrical section to have a cutting area in the area of the opening, with which the detachment of the thrombus can be assisted.

Furthermore, the receiving element can have a proximal, essentially funnel-shaped section which is connected to the actuating device, in particular the suction and/or pressure device. The funnel shape of the proximal end of the receiving element has the advantage that once the receiving element has received a thrombus, it can easily be withdrawn into a catheter, with the receiving element being compressed. The picked-up thrombus is held firmly in the pick-up element and pulled back together with this into a catheter for final removal.

In a preferred embodiment of the device according to the invention, the cover of the receiving element closes fluid-tight with the actuating device, in particular the pressure line. This ensures that the pressure generated only acts on the clot within the cavity, in particular the proximal cavity. In particular when using fluids to generate a negative pressure, it is prevented that, for example, blood is pumped out of the surrounding blood vessels. Rather, for example, a negative pressure can be achieved in the proximal cavity by pumping out a minimal volume of fluid.

An end element, in particular an umbrella, is preferably assigned to the receiving element, which can be positioned distally to a calculus during use. The terminating element can act as a filter in this case, so that it is prevented that particles that may detach from the thrombus are flushed into vessels lying downstream. Furthermore, the receiving element, in particular the opening of the receiving element, can be closed with the closing element as soon as the calculus or the thrombus is arranged in the receiving element. Thus, the thrombus can be essentially completely encapsulated in the receiving element.

The closure element can have a fluid-tight cover which is adapted to form a distal cavity in cooperation with at least the calculus. This embodiment is particularly suitable for combination with the closable proximal cavity formed by the fluid-tight cover of the receiving element. This has the advantage that a safety function is achieved in the event that the calculus does not close the proximal cavity so tightly that a negative pressure can build up in the proximal cavity. This could be the case, for example, if part of the thrombus detaches, creating a larger channel that equalizes the pressure in the proximal cavity. In this context, it is pointed out that a completely tight closure of the cavity, in particular the proximal cavity, by the calculus is not required to create the negative pressure as long as the channels or openings in the thrombus are so small that there is at least temporarily a sufficiently high pressure drop between the proximal and distal sides of the thrombus or calculus is adjustable.

The embodiment described above has the advantage that - in the event that a sufficient pressure drop cannot be achieved, the closing element or its fluid-tight cover takes over the sealing function, so that it is prevented that a large amount of blood is sucked in from the distal side of the calculus . In addition, this embodiment has the advantage that the physiological pressure then acts on the closing element serving as the closing element or its fluid-tight cover, whereby a force directed in the proximal direction is generated on the closing element, which pushes the closing element together with the calculus in the direction of the receiving element .

The closing element is advantageously fluidly connected to the pressure line assigned to the receiving element or to a further, separate pressure line in such a way that a different pressure can be set in the distal cavity than outside the distal cavity for moving, in particular for loosening, the calculus. The advantages described in connection with the proximal cavity, which is formed by the cover of the receiving element and at least the calculus, essentially apply equally to the closing element provided with the cover. In particular, this embodiment has the advantage that by setting an overpressure in the distal cavity between the calculus and the closing element, the thrombus or the calculus in general is displaced in the direction of the receiving element. In contrast, in the proximal cavity between the calculus and receiving element, the movement of the calculus in the direction of the receiving element is initiated by the negative pressure generated in the proximal cavity. In addition, in this embodiment, the overpressure generated in the distal cavity leads to a radial expansion of the vessel, which makes it easier to detach the clot. Furthermore, the removal of the clot can be aided by anticoagulant drugs, such as thrombolytics, which are introduced into the distal cavity. The medication can be supplied through the pressure line.

In a preferred embodiment of the device according to the invention, the closing element and the receiving element are fluidly connected to the actuating device, in particular the suction and/or pressure device, in such a way that a device arranged between the cavities is arranged between the distal cavity and the proximal cavity for moving, in particular for releasing Concrement different, in particular changeable, relative pressures are adjustable. The pressure gradient that develops between the pressure in the distal cavity and the pressure in the proximal cavity, i.e. across the calculus, is decisive for the detachment of the thrombus. The relative pressures in the two cavities can therefore be adjusted in such a way that, for example, a relatively high pressure can be generated in the distal cavity and a relatively low pressure can be generated in the proximal cavity in order to move the clot into the receiving element. This increases the pressure drop and hence the force on the clot to loosen and move it. A positive or negative pressure can be generated in each of the cavities independently of one another. In particular, there is the possibility of generating an overpressure in the proximal cavity by supplying liquid and a negative pressure in the distal cavity by removing liquid. As a result, the thrombus moves in a distal direction, the excess pressure in the proximal cavity causing the vessel to widen proximally, thereby enabling the thrombus to detach. A pressure reversal and thus a reversal of movement can follow.

The closing element and the receiving element can be connected to a common pressure-generating unit. In this way, the pressure drop required to loosen the clot can be set centrally.

The common pressure generation unit is preferably arranged extracorporeally and comprises at least one oscillating partition wall, in particular a pressure membrane, which is or can be fluidly connected to the closing element and/or the receiving element at least during use. The pressure in the cavities can be set and varied easily and precisely by the pressure membrane. For this purpose, the overpressure or underpressure can be generated in a simple manner in the proximal and distal cavities on both sides of the calculus by supplying fluid (overpressure) or removing fluid (underpressure). A simple syringe can be used in place of the oscillating pressure diaphragm to intuitively control fluid delivery and drainage, allowing the physician to manually control the force and frequency needed to loosen the thrombus by alternately pulling and squeezing the syringe. It is therefore generally disclosed in this connection that the common pressure generating unit, for example the syringe or another piston/cylinder arrangement, is arranged extracorporeally. The pressure membrane and the syringe also have the advantage that the pressure in the two cavities can be changed independently of one another. In particular, can be generated in this way in a cavity, a negative pressure and at the same time in the other cavity, an overpressure, the ses pressure drop can be quickly and easily reversed or inverted.

Alternatively, the common pressure generating unit can comprise a feed pump, in particular an intracorporeal feed pump, which is arranged within the pressure line in such a way that the feed pump is fluidly connected or can be fluidly connected to the closing element and/or the receiving element at least during use. As a result, the volume of fluid to be moved to generate pressure is reduced compared to an extracorporeal pump, since the essentially ineffective dead volume present in the pressure line is not moved. The intracorporeal feed pump is therefore particularly efficient. Another advantage of the feed pump is that there are no liquids in the feed system, only power cables or a pump shaft. This has the advantage that the system can be dimensioned with very small diameters.

The pressure generation unit, in particular the common pressure generation unit, is preferably assigned a control unit, which is adapted in such a way that a pressure change in at least one, in particular both, cavities can be controlled as a function of frequency, in particular in a pulsating manner, in particular in the form of a sine curve, in particular a sine magnitude curve. The pressure distally and proximally of the clot is advantageously varied over time, so that the pressure gradient between the two cavities changes in its effective direction. This can be done, for example, by alternately supplying and removing fluid volumes in one cavity or both cavities, so that the clot is made to vibrate, which facilitates the detachment of the clot from the vessel wall. The pressure change can be sinusoidal, with the time course of the pressure change in front of and behind the clot being matched to one another. Other changes in pressure over time are also possible, for example in the form of a sine curve, i.e. fluid volumes are discharged alternately in both cavities, for example.

The control unit can also include at least one pressure measuring element, which is connected to the suction and/or pressure device in such a way that the pressure that can be generated in the cavities can be measured and/or adjusted. In this way it can be achieved that the detachment of the thrombus from the vessel wall is detected, since a characteristic change in pressure is generated when the thrombus detaches. Furthermore, the pressure in the cavities is limited by the pressure-dependent control, which reduces the risk of injury in the vessel, since overexpansion or collapse of the vessel is avoided.

In a further preferred embodiment of the device according to the invention, a flexible, fluid-tight membrane is provided which is operatively connected to at least one distal end of the receiving element on the one hand and to the actuating device on the other hand. The flexible membrane preferably forms a chamber with the cover of the receiving element, which is fluidly connected to the suction and/or pressure device, in particular the pressure line, such that during use the pressure in the proximal cavity can be adjusted by the pressure in the chamber. In this way, the actuating medium, for example a liquid, is kept entirely within the device, so that the actuating medium does not interact with, for example, the blood outside the cavity. The risk of injury and infection for the patient is thus reduced. At the same time, body fluids are prevented from penetrating into the device and impairing the function of the device. If the device is equipped with such a flexible membrane, the actuating medium can also comprise a wire which is connected to the membrane, so that the pressure within the proximal cavity can be generated by tensioning or relaxing the membrane. In this variant, the pressure is generated by simply pulling the wire, which is a well-known and easy-to-use procedure in medicine, especially in interventional radiology. Furthermore, the wire provides feedback so that the user can develop a feel for the force required to remove the thrombus and can dose it properly. The flexible membrane or the chamber formed by the membrane represents an effective sub-cavity within the proximal cavity, which assumes the function of receiving and generating pressure or negative pressure.

The receiving element preferably comprises a proximal end section which is essentially cylindrical and connected to the cavity, the longitudinal axial extension of the end section being adapted such that the end section is at least partially arranged in the delivery device during use. The proximal end section thus has the function of connecting the receiving element for the calculus and the delivery device in the expanded state, insofar as the longitudinal axial extent of the end section is dimensioned or adapted such that the end section in use, i.e. in the expanded state of the receiving element, at least is partially arranged in the feeder. This embodiment is suitable, without being limited to it, for the combination with the embodiment in which the delivery device itself is designed as a pressure line or as an aspiration catheter. This has the advantage that the cross The average diameter of the suction and/or pressure device or the supply device can be relatively large throughout, so that the efficiency of the pressure/vacuum generation in the proximal cavity between the fluid-tight cover and the calculus to be removed is increased. The proximal end portion may have an outside diameter that corresponds to the inside diameter of the delivery device. As a result, pressure losses in the supply system or through the supply system are avoided or at least reduced.

The proximal end section and the receiving element, in particular the funnel-shaped and the cylindrical section, are preferably designed in one piece. In this way, the manufacture of the device is simplified.

The cylindrical section and/or the funnel-shaped section and/or the proximal section can comprise a braid. The wire elements can be twisted, woven or intertwined with one another or generally arranged to cross several times. The braid has the advantage that the receiving element has a high degree of flexibility, so that the device can be used in vascular curvatures.

In a further embodiment, at least the cylindrical section comprises a cross braid, in particular with axially arranged bands. In this case, at least the proximal end section can also comprise a braid with a spiral winding, in particular with axially arranged bands, or an asymmetrical braid. The various types of braiding mentioned above can merge into one another in such a way that, for example, the cross-braiding of the cylindrical section merges into a spiral winding of the end section and/or the funnel-shaped section. The advantage of the axially arranged ribbons in the spiral wound braid is that the ribbons can absorb tensile forces and the spiral winding can absorb shear forces. The advantage of the cross-braid with axially arranged ribbons is that the axial force absorption is improved with relatively little elongation. The advantage of the asymmetrical braid is that it is highly flexible and can absorb forces and torques in the proximal and distal axial direction.

In the case of the asymmetrical lattice braiding, the wire elements which overlap or cross one another in the crossing areas have different angles or braiding angles with respect to a straight line running in the axial direction. The different braiding angles ensure that the wire elements, which can easily slide over one another in the case of symmetrical lattice braiding, block each other so that a particularly stable lattice structure is formed. The asymmetrically braided proximal end section can thus absorb both axial forces and torques. The latticework of the receiving element, which is continued or braided further in the area of the proximal end section, leads to a particularly stable structure of the proximal end section due to the asymmetrical arrangement of the wire elements.

In a further preferred embodiment, the proximal end section and the supply device each have an end stop such that an axial movement of the receiving element in the distal direction can be limited. The proximal end section can be arranged in the delivery device so that it can move axially, so that the receiving element can be moved relative to the delivery device for positioning in a body vessel. The feed movement is limited or can be limited by the interaction of the end stop of the proximal end section and the end stop of the delivery device, so that the receiving element is prevented from becoming detached from the delivery device. Rather, part of the proximal end portion is retained in the delivery device. The end stops thus function as retaining means and, in the stop position, seal the connection between the end section and the feed device. The entire lumen of the delivery device or microcatheter can thus be used to generate the pressure or negative pressure in the cavity. Another advantage is that when navigating the delivery device or the microcatheter to the calculus, i.e. to the treatment site, there are no other components, in particular catheter-like elements, in the delivery device, which means that the delivery device is highly flexible and the risk of injury is reduced.

The end stop of the proximal end portion may include at least one sleeve connected to the outer periphery of the proximal end portion. The sleeve is a simple means to locally increase the outer diameter of the proximal end portion to form the end stop. The sleeve also means that the connection between the end section and the feed device or generally between the receiving element and the feed device, which results in the stop position, is relatively short.

It is also possible to provide more than one sleeve on the proximal end section, with the further proximally arranged sleeves or one further proximally arranged sleeve improving the guidance of the basket or of the receiving element.

The sleeve can be connected to the proximal end section materially, positively, non-positively or by another coaxially arranged sleeve, with the proximal end section being clamped between the two sleeves. The integral connection between the sleeve and the proximal end section can take place, for example, by welding, gluing, by spraying on the sleeve or by soldering.

The clamping connection, in which the proximal end section is clamped between a sleeve arranged radially on the outside and a sleeve arranged radially on the inside and coaxially, has the advantage of a secure mechanical connection that is easy to produce.

The end stop of the delivery device or of the microcatheter can comprise at least one sleeve which is connected to the inner circumference of the delivery device. This version of the end stop is easy to manufacture.

A further possibility is that the end stop comprises part of the distal tip of the delivery device, with the part of the distal tip extending radially inwards and having a smaller inner diameter than a proximal part of the delivery device. In this embodiment, the end stop can be easily produced, for example, by reshaping the feed device in the area of the distal tip.

The delivery device can have an axially movable adapter arranged in the delivery device, which is detachably connected to the receiving element, in particular to the proximal end section or to the funnel-shaped section, such that the receiving element can be moved axially relative to the delivery device. The detachable connection between the adapter and the receiving element or between the adapter and the proximal end section has the advantage that the receiving element can be connected to an actuating element, for example to a guide wire, for positioning through the adapter. The receiving element can then be moved in the proximal and distal axial direction through the adapter or through the guide wire connected to the adapter. When the receiving element is positioned, the adapter can be removed from the receiving element, in particular from the proximal end section, and from the supply device, so that it fulfills its dual function, namely the supply of the receiving element and the pressure supply.

In a further preferred embodiment, the receiving element, in particular the proximal end section, is formed in one piece with the supply device, in particular with the actuating device or with the suction and/or pressure device. The result of this is that the suction and/or pressure device comprises a relatively large lumen, so that the handling of the device is improved and the efficiency of the treatment is increased. It is also possible for the receiving element to be controllable by the proximal end section formed in one piece with the supply device, in particular with the actuating device or the suction and/or pressure device. The receiving element preferably has a lattice structure which extends in the proximal direction into the delivery device and thus forms the actuating device, in particular a guide catheter. The lattice structure can comprise an asymmetrical lattice mesh at least in the proximal end section or in the section in which the lattice structure forms the actuating device. In this way, the receiving element can be controlled with the lattice structure continued into the supply device, in particular moved in the distal or proximal direction, with the variant having an asymmetrical lattice structure in the region of the proximal end section achieving additional stability of the actuating device.

A further aspect of the invention is to provide a previously described device for removing calculus from body vessels with an end element which, in use, can be positioned distally to a calculus and comprises a fluid-tight cover which is used to form a distal cavity for cooperation with at least one calculus is adapted, the closing element being operatively connected to the suction and/or pressure device in such a way that a different pressure can be set in the distal cavity for moving, in particular for loosening, the calculus than outside the distal cavity.

• 1 einen Längsschnitt durch eine Vorrichtung zum Entfernen von Konkrementen nach einem erfindungsgemäßen Ausführungsbeispiel im Gebrauch;
• 2 einen Längsschnitt durch eine Vorrichtung nach einem weiteren erfindungsgemäßen Ausführungsbeispiel im Gebrauch;
• 3 einen Längsschnitt durch die Vorrichtung gemäß 2 im komprimierten Zustand;
• 4 einen Längsschnitt durch eine Vorrichtung nach einem weiteren erfindungsgemäßen Ausführungsbeispiel;
• 5 einen Längsschnitt durch eine erfindungsgemäße Vorrichtung nach einem weiteren bevorzugten Ausführungsbeispiel im Gebrauch;
• 6 einen Längsschnitt durch eine Druckleitung der Vorrichtung gemäß 5;
• 7 einen Längsschnitt durch eine Druckerzeugungseinheit der Vorrichtung gemäß den 2 bis 4 nach einem erfindungsgemäßen Ausführungsbeispiel;
• 8a, 8b jeweils ein Zeit-/Druckdiagramm für den proximalen und den distalen Hohlraum der Vorrichtung gemäß 5 nach einem bevorzugten Ausführungsbeispiel;
• 9a, 9b jeweils einen Längsschnitt durch eine Vorrichtung nach einem weiteren, erfindungsgemäßen Ausführungsbeispiel;
• 10 einen Längsschnitt durch eine Vorrichtung nach einem weiteren, erfindungsgemäßen Ausführungsbeispiel;
• 11 eine Seitenansicht einer Vorrichtung nach einem weiteren, erfindungsgemäßen Ausführungsbeispiel;
• 12a eine Seitenansicht einer Vorrichtung nach einem weiteren, erfindungsgemäßen Ausführungsbeispiel mit einer Variante der Endanschläge;
• 12b eine Seitenansicht einer Vorrichtung nach einem weiteren, erfindungsgemäßen Ausführungsbeispiel mit einer weiteren Variante der Endanschläge;
• 13a eine Seitenansicht einer Vorrichtung nach einem weiteren, erfindungsgemäßen Ausführungsbeispiel, bei dem der proximale Endanschlag mit einem Adapter lösbar verbunden ist;
• 13b eine Variante einer korbseitig angeordneten Hülse, die mit dem Adapter verbindbar ist ;
• 14a eine Seitenansicht einer Vorrichtung nach einem weiteren, erfindungsgemäßen Ausführungsbeispiel im komprimierten Zustand; und
• 14b eine Seitenansicht der Vorrichtung gemäß 14a im expandierten Zustand.

The invention is explained in more detail below using exemplary embodiments with reference to the attached schematic drawings. show in it

• 1 a longitudinal section through a device for removing calculus according to an embodiment of the invention in use;
• 2 a longitudinal section through a device according to a further embodiment of the invention in use;
• 3 according to a longitudinal section through the device 2 in the compressed state;
• 4 a longitudinal section through a device according to a further embodiment of the invention;
• 5 a longitudinal section through a device according to the invention according to a further preferred embodiment in use;
• 6 according to a longitudinal section through a pressure line of the device 5 ;
• 7 a longitudinal section through a pressure generating unit of the device according to 2 until 4 according to an embodiment of the invention;
• 8a , 8b Figure 12 shows a time/pressure diagram for the proximal and distal lumens of the device, respectively 5 according to a preferred embodiment;
• 9a , 9b each a longitudinal section through a device according to a further embodiment of the invention;
• 10 a longitudinal section through a device according to a further embodiment of the invention;
• 11 a side view of a device according to a further embodiment of the invention;
• 12a a side view of a device according to a further embodiment of the invention with a variant of the end stops;
• 12b a side view of a device according to a further embodiment of the invention with a further variant of the end stops;
• 13a a side view of a device according to a further embodiment of the invention, in which the proximal end stop is detachably connected to an adapter;
• 13b a variant of a sleeve arranged on the basket side, which can be connected to the adapter;
• 14a a side view of a device according to a further embodiment of the invention in the compressed state; and
• 14b a side view of the device according to FIG 14a in the expanded state.

In general, the present application discloses a device for removing calculus 51 from blood vessels 50 or other body cavities, comprising a containment member 20 having a relatively smaller cross-sectional diameter compressed state and a larger cross-sectional diameter expanded state. The receiving element 20 is preferably arranged in a supply device 10 or a catheter for insertion and positioning in a blood vessel 50 . In order to receive the clot 51, the receiving element 20 can be moved relative to the catheter, in particular in the distal direction. The receiving element 20 is adapted to assume the expanded state automatically. The catheter can include a suction and/or pressure unit, in particular a suction unit or an aspiration catheter, which is connected to the receiving element 20 . At the proximal end of the catheter, the device can also include an operating unit that interacts with the catheter for insertion into the blood vessel 50 and/or with the receiving element 20 for transferring the receiving element 20 from the compressed to the expanded state.

1 1 shows an embodiment of a device according to the invention for removing calculus in use, ie when picking up a calculus or clot 51. The device comprises a receiving element 20 which is arranged distally to the actuating device 11. FIG. The receiving element 20 is basket-like or funnel-shaped and has a funnel-shaped section 24 that tapers in the proximal direction. The funnel-shaped section 24 is connected in the distal direction to a cylindrical section 22, in particular connected coaxially. The cross-sectional diameter of the cylindrical section 22 of the receiving element 20 essentially corresponds to the diameter of the blood vessel 50, so that the cylindrical section 22 rests against the vessel wall in the expanded state and supports it. At the distal end 26 of the receiving element 20, the cylindrical section 22 forms a receiving opening 23 which can be closed at least temporarily by the calculus or clot 51 to be removed (see Fig. 1 ). The distance between the receiving opening 23 and the funnel-shaped section 24 or generally the proximal end of the receiving element 20 is dimensioned such that the calculus or clot 51 to be removed can be completely or at least largely received in the receiving element 20 .

The receiving element 20 can also have a different shape than that in 1 shown shape. For example, the receiving element 20 can have a shortened cylindrical section 22 such that the receiving element 20 is essentially funnel-shaped up to the receiving opening 23 . The receiving element 20 can also be conical, at least in sections. In addition to the rotationally symmetrical Shape of the receiving element 20, other cross-sectional profiles can be realized.

The receiving element 20 is also provided with at least one cover 21 or with a coating or a covering, which can be formed integrally or in one piece with the receiving element 20 . The cover 21 forms a fluid-tight wall of the receiving element 20. The cover 21 can be produced by sputtering or another coating method as a self-supporting support structure. The cover 21 can be firmly connected to a lattice structure of the receiving element 20 . In this case, the cover 21 can be arranged both on an inner surface of the receiving element 20 and on an outer surface or an outer circumference of the receiving element 20 . The cover 21 can extend over the entire receiving element 20 or only partially cover the receiving element 20, with the cover 21 extending at least so far over the vessel cross section during use that the blood vessel 50 is essentially completely closed in the proximal direction. For example, the cover 21 can only cover the funnel-shaped portion 24 . The cover is made of a fluid-tight material or film that is sufficiently strong or tight to withstand a pressure difference between the inside and the outside of the cover 20 .

As in 1 shown, the cover 21 or the receiving element 20 forms a recess or a proximal cavity 30a that is curved in the proximal direction. The cover 21 or the cavity 30a itself can be closed by the calculus to be removed. This means that the diameter of the cavity 30a or of the receiving element 20 corresponds approximately to the diameter of the calculus to be removed. The fluid-tight cover 21 extends so far in the distal direction, in particular as far as the receiving opening 23, that the proximal cavity 30a in cooperation with the calculus 51 is closed off essentially in a pressure-tight or fluid-tight manner. The proximal cavity 30a is essentially cut off from the surrounding blood flow in the vessel 50 on all sides by the fluid-tight cover 21 on the one hand and the calculus 51 to be removed on the other. Overall, it is important that the fluid-tight cover 21 is designed in such a way that the receiving element 20 fulfills two functions, namely the function of an overpressure and/or negative pressure space for moving, in particular for loosening the calculus, and the function of an receiving space for the calculus detached from the vessel 51.

With regard to the release function of the receiving element 20, the actuating device 11 is assigned to it, which is operatively connected to the cover 21 and/or the cavity 30a, at least during use. The actuating device 11 is provided and designed to move the calculus 51 in the cavity 30a in cooperation with the cover 21 and/or the cavity 30a, in particular to set a different pressure than outside of the cavity 30a, in particular to loosen the calculus to be removed in an area distal to the calculus 51. For this purpose, the actuating device 11 specifically includes a pressure line 15, in particular a proximal pressure line 15a. The proximal pressure line 15a is connected at its distal end to the receiving element 20, in particular to the funnel-shaped section 24 of the receiving element 20. The tubular contour of the proximal pressure line 15a continues in part into the receiving element 20 . The pressure line 15 is, as in 1 shown, arranged inside the delivery device 10, for example inside a microcatheter. The pressure line 15, 15a can also be arranged outside of the feed device 10 or be formed by the feed device 10 itself. The actuating device 11 also includes a suction and/or pressure device (not shown) which is fluidly connected or can be fluidly connected to the cavity 30a via the pressure line 15, 15a. An actuating medium 14, in particular a liquid, can be pumped into the cavity 30a and/or sucked out of the cavity 30a by means of the suction and/or pressure device. By supplying liquid, the pressure in the proximal cavity 30a can be increased by means of the actuating device 11 or the suction and/or pressure device if, as in 1 is closed at the distal end by the calculus to be removed. The pressure in the cavity 30a is lowered below the physiological pressure (negative pressure) by liquid removal or suction of the liquid located in the cavity 30a. This means that the physiological pressure acts on the side of the calculus 51 facing away from the cavity 30a, as shown in FIG 1 marked arrows. This generates a force acting in the proximal direction, ie in the direction of the receiving element 20, on the calculus 51, which pushes the calculus 51 into the receiving element 20 or the receiving basket. In order to support the loosening of the calculus 51 from the vessel wall, an overpressure and underpressure can be generated alternately in the cavity 30a.

The receiving member 20 is generally stent-like in structure and may be either braided from wires or laser cut from a tube. A combination of a wire mesh and a A laser-cut structure is possible, for example the funnel-shaped section 24 can be braided and the cylindrical-shaped section 22 can be laser-cut. Preferably, the receiving member 20 is made of a shape memory material such as nitinol. The cover 21 can comprise a plastic foil or metal foil, for example. Particularly suitable plastics are polyurethane, PTFE or silicone. The metal foil can be produced by a sputtering process. The cross-sectional diameter of the receiving element 20 can be between 1 mm and 10 mm, in particular 2 mm and 8 mm, in particular 3 mm and 6 mm. Depending on the application, it is also possible for the receiving element 20 to have a cross-sectional diameter of between 0.5 mm and 20 mm, in particular 1 mm and 18 mm, in particular 2 mm and 15 mm. The length of the receiving element 20 also depends on the respective application, in particular on the treatment site, and can vary between 3 mm and 100 mm, in particular 5 mm and 60 mm, in particular 10 mm and 22 mm.

• Derselbe Druckgradient herrscht auf der gesamten Fläche des Thrombus und schiebt den Thrombus homogen in den Korb. Die Handhabung ist für den Anwender besonders sicher und einfach, da dieser den Unterdruck durch begrenzte Volumenänderungen erzeugt, wobei der Unterdruck beliebig und mit kontrollierter Geschwindigkeit erhöht oder auch verringert wird abhängig vom Widerstand, der vom Thrombus ausgeübt wird. Die Bewegung des Thrombus ist durch die Kraft spürbar, die der Anwender zur Erzeugung des Unterdruckes ausübt. Er kann den Thrombus mit abwechselnden, regelmäßigen Unterdruck- und Ausgleichphasen aus der Gefäßwand ablösen.

Overall, in the embodiment according to 1 the following advantages or effects:

• The same pressure gradient prevails over the entire surface of the thrombus and pushes the thrombus homogeneously into the basket. Handling is particularly safe and easy for the user, since the negative pressure is generated by limited changes in volume, with the negative pressure being increased or decreased at will and at a controlled speed, depending on the resistance exerted by the thrombus. The movement of the thrombus can be felt through the force that the user exerts to create the negative pressure. He can detach the thrombus from the vessel wall with alternating, regular negative pressure and equalization phases.

For this purpose, a proximal basket spreads out from a catheter (Nitinol, superelastic area) and lies against the vessel wall. The basket is covered by a dense structure so that the proximal side of the thrombus is isolated from the flow conditions in the circulatory system. The basket is connected to the catheter. Defined changes in volume in the catheter create a negative pressure that acts on the entire proximal surface of the thrombus. The negative pressure is understood in relation to the blood pressure that prevails behind the thrombus. If the pressure behind the thrombus is 50 mmHg, a pressure of 20 mmHg in front of the thrombus is defined as negative pressure. This effect can be viewed as an inversion of the pressure gradient from distal to proximal. High "arterial" pressure can prevail distal to the thrombus if collateral vessels bypass the occluded segment of the vessel and bring high-pressure blood behind the thrombus. A pressure of about 80 mmHg can prevail behind the thrombus. With a pressure gradient of about 100 mmHg in a vessel with a diameter of 3 mm, a total force on the thrombus of about 20 g could be generated.

However, smaller forces are already sufficient to move the thrombus against the low adhesion to the vessel wall. The extent of the volume change can be defined very precisely by the user. It can e.g. B. done with a syringe that is connected to the catheter. When a volume has been aspirated, a negative pressure is created in the entire space between the basket and the thrombus. Above a certain negative pressure, the entire thrombus moves in the direction of the basket. The procedure can be carried out very slowly and thus differs significantly from previous concepts in which high blood velocity is required to remove the thrombus.

According to a further exemplary embodiment, a closing element 40 is arranged distally to the receiving element 20 ( 2 ). The closure element 40 is essentially drop-shaped or umbrella-shaped and, like the receiving element 20 , can be compressed to a minimum cross-sectional diameter for insertion into the blood vessel 50 . The terminating element 40 is connected centrally to a wire 14b, or is mounted on the wire 14b in an axially displaceable manner and fixed by stops. The wire 14b extends axially to the longitudinal axis of the receiving element 20 and the closing element 40. The wire 14b is guided in the actuating device 11 and can be moved at least in the axial direction. During use, the wire 14b penetrates the clot 51. Similar to the receiving element 20, the closing element 40 has at least partially a distal cover 41, which extends at least far enough over the closing element 40 that the blood vessel 50 distal to the clot 51 is essentially completely blocked or closed .is closed. The distal cover 41 delimits a distal cavity 30b with the vessel wall of the blood vessel 50 and the clot 51 . A stop 43 is formed at the proximal end of the termination member 40 which, in use, cooperates with the wire 14b of the actuator 11 such that the clot 51 is manually movable into the receiving member 20 . The closing element 40 can be provided with the distal cover 41 in the area of the stop 43 . It is also possible for the closing element 40 to have an open structure, for example a filter structure, in the area of the stop 43, so that the distal cavity 30b extends to the distal end of the closing element 40 extends. The closing element 40 comprises an umbrella-like section 44 in the distal area, which is provided with the distal cover 41 . The umbrella-like section 44 can also have an open structure, in particular a filter structure, if the stopper 43 is equipped with the distal cover 41 .

According to FIG 2 leads to a further improvement in the safety of the removal system or retriever, since any thrombus particles that may become loose are effectively stopped by the closing element 40, so that a further vascular occlusion downstream is avoided. In addition, the release force generated by the negative pressure in the proximal cavity 30a is mechanically increased by the closing element 40 when the closing element 40 is pulled against the thrombus or the calculus in the proximal direction. In this respect, it is a combined hydraulic/mechanical system. The pressure line is in 2 not shown explicitly or can be designed in such a way that the wire 14b is guided in the pressure line 15 . Alternatively, the wire 14b can be designed as a hollow wire and represent an extension of the pressure line 15, which has supply and discharge openings for the actuating medium in the region of the cavity 30a.

In order to receive the clot 51, the closing element 40 is moved relative to the receiving element 20, in particular in the proximal direction, so that the closing element 40, in particular the stop 43, closes the receiving opening 23 of the receiving element 20 in order to completely encapsulate the clot 51 in the receiving element 20. For the final removal of the clot 51 from the blood vessel 50, the actuating device 11, the receiving element 20 and the closing element 40 are moved in the proximal direction and into a tube-like catheter 10a, which has a larger diameter than the supply device 10, and to remove the thrombus or clot 51 serves. The funnel-shaped section 24 of the receiving element 20 causes the receiving element 20 to be converted into the compressed state. Likewise, the closing element 40 is transferred to the compressed state, since the receiving opening 23 of the receiving element 20, which narrows when it is pulled back into the feed device 10, presses and compresses the closing element 40 ( 3 ).

4 shows a further exemplary embodiment of the device according to the invention, with the receiving element 20 and the closing element 40 having essentially the same structure as already shown in FIG 2 described. One difference is that the closing element 40 is connected centrally to a pressure line 15 instead of to a wire 14b, which carries an actuating medium 14, in particular a fluid 14a. In principle, the actuation of the device for loosening a calculus or clot 51 can therefore be effected either by a mechanical actuation medium, for example a wire 14b, or by a fluid 14a, ie a liquid or a gas.

In the area of the closing element 40, in particular between the stop 43 and the umbrella-like section 44, the pressure line 15 has proximal pressure openings 42a, through which the fluid 14a can flow into the distal cavity 30b. In the embodiment according to 4 the closing element 40 has a distal cover 41 in the area of the umbrella-like section 44, whereas the stop 43 comprises a substantially open structure. The distal cavity 30b thus extends from the umbrella-like section 44 to the calculus or clot 51. The fluid 14a flowing through the distal pressure openings 42b into the distal cavity 30b causes an increase in pressure in the distal cavity 30b, so that between the distal cavity 30b and a pressure gradient develops in the proximal cavity 30a. The force acting on the clot 51 due to the pressure drop causes the clot 51 to be loosened and moved into the receiving element 20 . It is possible that the receiving element 20 does not have a cover 21 but is designed as a receiving basket with an open lattice structure. The receiving element 20 can also assume a filter function, ie the lattice structure is designed to be tightly meshed in order to hold back particles of the clot 51 that are loosening.

As in 5 clearly recognizable, the pressure line 15 can also have proximal pressure openings 43a in the region of the proximal cavity 30a. The receiving element 20 is provided with a proximal cover 21 to form the proximal cavity 30a. The two cavities 30a, 30b are advantageously coupled to a pressure generating unit 13 via separate pressure lines 15, a proximal pressure line 15a being associated with the proximal cavity 30a and a distal pressure line 15b being associated with the distal cavity 30b. The distal pressure line 15b can run inside the proximal pressure line 15a. Alternatively, a 2 or more lumen catheter can be used.

In a preferred embodiment, the two cavities 30a, 30b with a common pressure generating unit 16 operatively connected. In 6 shows an example of such a common pressure generating unit 16, in particular an intracorporeal pump 18, which is arranged centrally in a common pressure line 15 of the two cavities 30a and 30b. The intracorporeal pump 18 is in accordance with 6 designed as a screw conveyor or Archimedean screw and connected to a flexible shaft 18a with an extracorporeally arranged drive unit (not shown). The pump is arranged in such a way that liquid can be displaced from the proximal to the distal cavity 30a, 30b. The drive unit and the intracorporeal pump 18 together form a common pressure generation unit 16, which is preferably connected to a control unit (not shown), so that the conveying direction of the intracorporeal pump 18 can be reversed depending on the frequency. In this way, the volume of the actuating medium, the blood enclosed in the cavities 30a, 30b or also other body fluids is displaced between the cavities 30a, 30b. A negative or positive pressure can be set alternately in the cavities 30a, 30b. Regular pressure changes in the cavities 30a, 30b cause the clot 51 to vibrate and thus become detached from the vessel wall of the blood vessel 50.

Alternatively, an extracorporeal pump 17 can also be provided ( 7 ). The two cavities 30a, 30b are connected to the extracorporeal pump 17 by separate pressure lines 15a, 15b. The common pressure generation unit 16 or the extracorporeal pump 17 comprises two pressure chambers 17c, 17d, which are separated by a pressure membrane 17a. The pressure membrane 17a is flexible and can be made to vibrate or oscillate. Due to the oscillation of the flexible pressure membrane 17a, an overpressure or underpressure is alternately generated in the pressure chambers 17c, 17d, which is transmitted through the pressure lines 15a, 15b to the cavities 17a, 17b.

In general, the vibration of the clot 51 can be generated manually, electronically or mechanically. For example, the actuator 11 may comprise a syringe or a suitable handle or plunger to cause the clot 51 to vibrate or oscillate. Electronically triggered pressure changes can generate vibrations with frequencies of at least 1 Hz, in particular at least 5 Hz, in particular at least 10 Hz, in particular at least 100 Hz, in particular at least 1000 Hz, in particular at least 20,000 Hz, in particular at least 100,000 Hz.

The proximal pressure chamber 17c, i.e. the pressure chamber 17c associated with the proximal cavity 30, also includes a connection 17b to which a manual pressure-generating unit, for example a commercially available syringe or a suction device, can be connected. The manual pressure generation unit is used, for example, to suck the clot 51 into the receiving element 20 in a final step as soon as it has been detached from the vessel wall by the vibrations generated by the pressure membrane 17 .

The oscillation of the clot 51 is essentially brought about by the fact that an actuating medium 14, specifically a liquid, is alternately supplied or discharged in at least one of the cavities 30a, 30b. The change in pressure over time caused by this in front of and/or behind the clot 51 can take place, for example, in the form of a sinusoidal oscillation. The pressure-generating unit 13 or the common pressure-generating unit 16 can be controlled, for example, in such a way that liquid is alternately supplied to and discharged from the two cavities 30a, 30b. Such a control is shown in the diagram according to FIG 8a . The solid line represents the pressure profile in the proximal cavity 30a and the broken line represents the pressure profile in the distal cavity 30b. It is also possible that the oscillation of the clot 51 takes place due to the alternating liquid discharge in the cavities 30a, 30b, as in 8b shown (sine curve). Two independently acting pressure generators, for example two pressure membranes, are required to realize the pressure profile according to FIG. 8b. The membrane can also be assigned to only one of the two cavities 30a, 30b. Furthermore, the volume removal or supply can be carried out separately for each cavity 30a, 30b by means of a syringe, a handle or a plunger.

Another variant for generating pressure in the proximal cavity 30a is shown in FIG 9a and 9b . In this variant of the device according to the invention, the actuating medium 14 is designed as a wire 14b which is connected centrally to a flexible membrane 25. The flexible membrane 25 is hinged to the distal end 26 of the receiving member 20 and divides the proximal cavity 30a into a chamber 31 and a receiving cavity 32 . The wire 14b is guided in the actuating device 11. In order to move the clot 51 into the receiving element 20, a negative pressure is created in the receiving cavity 32, ie in the part of the cavity 30a which is arranged distally to the membrane 25, by moving the wire 14b relative to the actuating device 11 in the proximal direction. This stretches the flexible membrane 25 ( 9b ). Just as in the embodiment according to 4 it is with the off described here example, it is not necessary for the receiving element 20 to be provided with a proximal cover 21 .

As in 10 As can be seen, the negative pressure in the chamber 31 can also be generated by the receiving element 20 being covered in a fluid-tight manner with the proximal cover 21, which delimits a closed area with the flexible membrane 25, so that an actuating medium 40 , In particular a fluid 14a, a negative pressure is generated. This leads to a proximal movement of the membrane 25 , so that a negative pressure is also created in the receiving cavity 32 , which causes the clot 51 to be sucked into the receiving cavity 32 .

The receiving element 20 can, as in 11 shown, have a proximal end portion 20a at a proximal end. The proximal end portion 20a is preferably located within the delivery device 10, particularly when the device is in use. The length of the proximal end section 20a is dimensioned such that at least part of the proximal end section 20a is arranged in the delivery device 10 or in the microcatheter when the basket or receiving element 20 is expanded. The proximal end section 20a thus forms an extension of the funnel-shaped section 24 into the delivery device 10 in such a way that a stable connection is formed between the delivery device 10 and the receiving element 20 in the expanded state. The proximal cover 21 of the receiving element 20 extends into the delivery device 10 or at least closes with the delivery device 10 such that the delivery device 10 and the receiving element 20 form an essentially fluid-tight system, at least in the expanded state. The proximal cover 21 extends specifically over the cylindrical section 22, the funnel-shaped section 24 and the proximal end section 20a, so that the connection between the supply device 10 and the receiving element 20 is essentially sealed in a fluid-tight manner. In this way, the feed device 10 can be used simultaneously as a suction and/or pressure device, in particular as a pressure line 15 . The efficiency, in particular the suction power, of the suction and/or pressure device or of the pressure generation unit 16 is increased since the inside diameter of the pressure line 15 corresponds to the inside diameter of the supply device 10 .

In the embodiment according to 11 the receiving element 20, in particular the funnel-shaped section 22, is formed from a wire mesh. The funnel-shaped section 22 thus comprises a stent-like structure. Alternatively or additionally, the latticework can also form the funnel-shaped section 24 and continue into the proximal end section 20a. It is possible that the latticework, in particular the arrangement of the wire elements or wires, varies along the receiving element 20 . The cylindrical section 22 and the funnel-shaped section 24 can have a cross braid, for example. The proximal end portion 20a may also include a helical arrangement of the wire elements. The transition between different types of mesh can be smooth or continuous. It is also possible to provide the wire mesh of the receiving element 20, in particular the cylindrical section 22 and the proximal end section 20a, with wire elements or bands running in the axial direction, so that the stability of the device is increased in the axial direction. The axial bands can have the same material as the lattice meshwork of the receiving element 20. It is also possible for the axial bands to comprise a different material, in particular a more elastic material. The receiving element 20 can generally be formed in one piece. Suitable materials for manufacturing the receiving element 20 are shape memory materials, for example nickel-titanium alloys, or plastics.

The proximal end portion 20a of the receiving element 20 has according to 11 furthermore a proximal end stop 52a. In addition, a distal end stop 52b is provided, which is assigned to the feed device 10 and is firmly connected to it. The end stops 52a, 52b have overlapping diameters and are arranged in such a way that an axial movement of the receiving element 20, in particular of the proximal end section 20a, is limited in the distal direction. This prevents the receiving element 20 from exiting the feed device 10 completely. An axial relative movement is therefore possible between the supply device 10 and the receiving element 20 without the two components being separated from one another.

The proximal end stop 52a is arranged substantially on an outer peripheral surface of the proximal end portion 20a. The proximal end stop 52a can, for example, comprise a sleeve 53a, in particular a cylindrical sleeve 53a. The distal end stop 52b of the delivery device 10 forms a counter-element to the proximal end stop 52a and is arranged on an inner circumferential surface of the delivery device 10, so that the distal end stop 52b is aligned with the proximal end stop 52a in the axial direction. The distal end stop 52b may also include a sleeve 54 .

As in 11 shown, the proximal end section 20a can have a further sleeve 53c, which is located proximal to the stop sleeve 53a. The further proximal sleeve 53c improves the axial guidance of the receiving element 20 or of the basket. The advantage of the embodiments explained below according to 12a , 12b with only one stop sleeve 53a of the proximal end section 20a consists in the comparatively greater flexibility.

The connection between the end section 20a and the sleeve 53a can take place, for example, by welding, gluing, by injection molding or by soldering. Another example of connecting the sleeves is in 12b shown. There it can be seen that the stop sleeve 53a arranged radially on the outside is pressed with a further sleeve 53b arranged radially on the inside and coaxially. The end piece of the proximal end section 20a is arranged between the two pressed sleeves 53a, 53b and clamped between the two sleeves 53a, 53b.

The difference between the embodiment according to 11 and according to the two exemplary embodiments 12a and 12b is that the proximal end portion 20a in the embodiments according to 12a , 12b shorter than in the embodiment according to 11 is, with the longer version according to 11 results from the additional proximal guide sleeve 53c.

The sleeves 53a, 53b, 53c, 54 can be made of plastic, metal, shape memory metal or X-ray visible materials. The diameter of the proximal end section 20a is adapted to the inner diameter of the end stop 52b or the stop sleeve 54 of the feed device 10 . The inner diameters of the sleeves 53a, 54, which correspond approximately, are less than 1.0, in particular less than 0.9, in particular less than 0.8, in particular less than 0.7, in particular less than 0.5, in particular less than 0.4 , in particular less than 0.3 mm. The sleeve wall thickness of the sleeves 53a, 53b, 53c, 54 disclosed above is less than 80 μm, in particular less than 70, in particular less than 60, in particular less than 50, in particular less than 40, in particular less than 30 μm. The wall thicknesses mentioned above have the advantage that the smallest possible pressure drop occurs when the receiving element 20 is actuated. In addition, the gliding ability of the basket or of the receiving element 20 is improved by the small jump in caliber.

The edges of the sleeves can be rounded, which is conducive to low pressure loss and good sliding of the receiving element 20 or of the proximal end section 20a. Furthermore, the rounded edges of the sleeves are gentle on the coating or the cover 21.

As in the 12a , 12b shown, the end stop 52b of the supply device 10 can be designed as a sleeve, in particular as a catheter sleeve 54 . The connection between the sleeve 54 and the feed device 10 can be materially bonded, form-fitting, force-fitting. For example, the sleeve 54 can be glued or press-fitted to the catheter tip. It is also possible to form the end stop 52b as part of the catheter tip. The catheter tip 55 can be crimped, glued, pressed, thermoformed or formed by swaging, for example. It is also possible for the catheter or the delivery device 10 to have a multi-stage design. The delivery device can have a smaller diameter distally than at a proximal point of the delivery device 10. The change in diameter can take place in several sections, with the smallest distal diameter serving as the end stop for the basket sleeve 53a. In the area of the small diameter, the catheter or the delivery device is highly flexible. In the area of the larger diameters, the feed device is comparatively stiff.

The feed device is characterized by a high level of flexibility compared to other connection technologies and is easy to control.

The two end stops 52a, 52b form sealing means, so that the supply device 10 is connected to the receiving element 20 in a fluid-tight manner. The sealing between the receiving element 20, in particular the proximal cover 21, and the supply device 10 is effected by appropriately designing the tolerances of the end stops 52a, 52b, which can include stop sleeves, for example. Suitable tolerance values are known to those skilled in the art.

The embodiment according to 13a FIG. 1 shows a further improvement of the device, in which the receiving basket 20 or the receiving element 20 can be moved in both axial directions relative to the feed device 10. FIG. In this exemplary embodiment, too, the dual function of the feed device 10 is maintained, on the one hand for the feed of the receiving element 20 and on the other hand for the pressure supply. For this purpose, the supply device 10 has an adapter 56 which is arranged in the supply device 10 in an axially movable manner and is detachably connected to the receiving element 20, in particular to the proximal end section 20a. The adapter 56 can also be connected to the funnel-shaped section 24 . The receiving element 20 can be moved axially relative to the feed device 10 by the adapter 56 . At the distal At the end of the adapter 56 there is a connecting piece 57 which is detachably connected to a counterpart 58 of the basket sleeve 53a. As in 13a As can be seen, the counterpart 58 of the sleeve 53a protrudes beyond the proximal end of the proximal end section 20a and is adapted for detachable connection to the connecting piece 57. This means that the adapter 56 and the receiving element 20 can be connected temporarily for the purpose of placing and moving the receiving element 20 axially, respectively. The adapter 56 is part of a pushing and pulling device for the sleeve 53a of the end section 20a. For this purpose, the adapter 56 can be connected to a guide wire or a push catheter (not shown), for example. It is also possible for the adapter 56 to be connected in one piece to a catheter or guide wire arranged in the delivery device 10 or generally to an actuating element. The adapter 56 is only temporarily inserted into the catheter or into the delivery device 10 and used to move or place the receiving element 20 . Thereafter, the adapter 56 is removed from the feeder 10 .

The connection between the adapter 56 and the sleeve 53a can be made by positive locking, in particular by threads, by barbs or by a click system. As in 13a shown, the connecting piece 57 has radially outwardly extending lugs 57a, in particular pins, which engage in corresponding recesses in the counterpart 58 of the sleeve 53a. It is possible to have a single lug 57a, two lugs 57a (as in 13a shown), to provide three, four or more lugs 57a. The lugs 57a can be arranged symmetrically to one another. The lugs 57a or pins are each a rigid elevation that protrudes so far beyond the outer circumference of the connecting piece 57 that a force transmission from the connecting piece 57 via the lug 57a or the lugs 57a to the counterpart 58 of the sleeve 53a is possible . A very small height, for example less than 1 mm, can be sufficient for this. Other heights are possible. The lugs 57a provide the prerequisite for a form-fitting connection between the connecting piece 57 and the counterpart 58, the counterpart 58 being adapted accordingly for this purpose. It is also possible to form the nose 57a or the noses 57a from an elastic material, so that the adapter 56 can be separated from the sleeve 53a by overcoming an elastic spring force. The lug 57a or the lugs 57a can be designed to be retractable, in particular retractable against a radially outwardly acting spring force.

It is also possible according to the arrangement 13a reverse such that the lug 57a or lugs 57a are located on an inner surface of the counterpart 58 of the sleeve 53a. The connecting piece 57 has corresponding recesses which are adapted in such a way that a releasable positive connection can be produced between the adapter 56 and the sleeve 53a.

It is also possible that a different type of detachable connection is chosen. For example, the adapter 56 can have a connecting piece 57 with an external thread, which can be screwed into a corresponding internal thread of the counterpart 58 of the sleeve 53a. The thread can be designed as a helical profile in order to increase the flexibility of the adapter 56 . The adapter 56 can be made of plastic, metal, shape memory metal, or radiopaque materials.

An example of the sleeve 53a arranged on the basket side with counterpart 58 is shown in 13b 1 is shown showing a side view of sleeve 53a. The sleeve 53a comprises the counterpart 58a at the proximal end, which is adapted for detachable connection to the connecting piece 57 of the adapter 56 or the guide wire. The distal end of sleeve 53a is adapted for connection to basket 20 and includes a retaining portion 59a for this purpose. The holding section 59a is also in 13a shown. The proximal end of the basket 20 is arranged in the area of the holding section 59a and is firmly connected to an inner surface of the sleeve 53a, for example by gluing, soldering or pressing. Other types of connection are possible.

• Das Gegenstück 58 der Hülse 53a umfasst eine im Wesentlichen L-förmige Ausnehmung 58a mit einem in Axialrichtung der Hülse 53a erstreckten Längsschenkel, insbesondere Längsschlitz und einem im Wesentlichen in Umfangsrichtung der Hülse 53a erstreckten Querschenkel, insbesondere Querschlitz. Es ist möglich, die beiden Schenkel als Schlitze oder als Ausnehmungen auszubilden, die in der Innenfläche der Hülse 53a angeordnet sind, wobei die Außenfläche der Hülse geschlossen ist. Es ist auch möglich, den gemäß 13b rechtwinklig zum Längsschenkel angeordneten Querschenkel unter einem anderen Winkel anzuordnen, beispielsweise unter einem Winkel < 90°.

The counterpart 58 is structured as follows:

• The counterpart 58 of the sleeve 53a comprises an essentially L-shaped recess 58a with a longitudinal leg, in particular a longitudinal slot, extending in the axial direction of the sleeve 53a and a transverse leg, in particular a transverse slot, extending essentially in the circumferential direction of the sleeve 53a. It is possible to form the two legs as slots or as recesses arranged in the inner surface of the sleeve 53a, the outer surface of the sleeve being closed. It is also possible according to 13b perpendicular to the longitudinal leg arranged transverse leg to be arranged at a different angle, for example at an angle <90 °.

The number of recesses 58 corresponds to the number of lugs 57a.

The recess 58a interacts with the lugs 57a of the connecting piece 57 in the manner of a bayonet catch. The connection of the The parts are connected by a combined plug-and-turn movement, with a lug 57a being plugged into the longitudinal leg 58a of the recess and being secured by twisting in the region of the transverse leg of the recess 58a. To release the connection, the plug-and-turn movement takes place in reverse order.

Other possibilities for realizing the detachable connection between the counterpart 58, the sleeve 53a and the connecting piece 57 of the adapter 56 also exist. For example, instead of the L-shaped recess 58a, it is possible to provide a thread in the area of the counterpart 58, in which the lugs 57a or a counter-thread of the connecting piece 57 engage. Other types of connection, such as snap-in connections, are conceivable.

In the embodiment according to 13b the sleeve 53a is provided with a coil section 59 at least in the region of the distal end. This improves the flexibility of the sleeve 53a. The proximal end with counterpart 58 is rigid. It is also possible to make the distal area of the sleeve 53a rigid. To form the coil section 59, a spiral or helix is cut into the sleeve 53a, which extends approximately over 2/3 of the total length of the sleeve 53a. A shorter or longer helical coil section 59 is possible. In 13b the coil section 59 has three turns. A different number of turns, for example two or more than three turns, are possible.

It is also possible to form the entire sleeve 53a as a coil in such a way that the wall of the sleeve has a spiral structure over its entire length. In the area of the counterpart 58, the helical structure forms a thread in which the profile of the connecting piece detachably engages. The arrangement according to 13b can also be reversed, so that the proximal counterpart 58 is designed as a threaded coil. The distal holding section 59a can have a closed wall which is fixedly connected to the basket 20 .

In addition or as an alternative to the coil section 59, several longitudinal grooves can be provided in the region of the distal end, i.e. distally from the coil section 59, into which the proximal end of the basket is pressed, thereby creating a non-positive connection between the sleeve 53a and the basket 20. Other types of connection between the holding portion 59a and the basket 20 are possible, as described above.

When using the device according to 11 , 12a , 12b the receiving element 20, which is initially arranged in the compressed state within the supply device 10, is transported into the region of the treatment site. With the aid of an additional catheter, in particular a push catheter, which is temporarily arranged inside the delivery device 10, the receiving element 20 is moved in the distal direction relative to the delivery device 10. The receiving element 20 is thus pushed out of the delivery device 10 with the aid of the push catheter. The receiving element 20, in particular the cylindrical section 22 and the funnel-shaped section 24, widens or expands in the process. The feed movement of the receiving element 20 is limited by the two end stops 52a, 52b.

It is possible that the receiving element 20 is first loaded into the delivery device 10 in the compressed state, i.e. before the delivery device 10 is guided or navigated to the treatment site. Alternatively, the receiving element 20 can be loaded into the delivery device 10 when the delivery device 10 is already arranged in the area of the treatment site.

In order to guide or pull the receiving element 20 back into the delivery device 10 after the expansion in a body vessel, in a device according to FIG 11 , 12a , 12b a retraction means or catheter-like retrieval tool (not shown) may be provided, which is inserted into the delivery device 10 and advanced up to the proximal end section 20a. The retrieval tool can be connected to the receiving element 20 by suitable measures. In addition to the adapter according to 13a Other possible types of connection include form-fitting connections, for example a thread or a key bit. The connection can also be force-locked. For example, the catheter-like retrieval tool can include a microballoon that is advanced into the funnel-shaped portion 24 of the receiving member 20 . The microballoon arranged in the funnel-shaped section 24 is inflated so that a non-positive or frictional connection is created between the funnel-shaped section 24 and the microballoon. The frictional force between the microballoon and the funnel-shaped section 24 is sufficient to retract the receiving element 20 into the delivery device 10 .

According to a further exemplary embodiment, the device can be designed entirely in one piece. In this case, the supply device 10 and the receiving element 20 form a single, tube-like or catheter-like component. 14a shows a device designed in this way in the compressed state of the receiving element 20. The compressed receiving element 20 and the feed device 10 essentially have the same cross-section knife and form a tubular or hose-like body. The delivery device 10 forms a rigid portion 60 of the tubular body and is arranged substantially proximally. Disposed distally of the rigid portion 60 is a flexible portion 61 which forms the receiving member 20 in use. The rigid section 60 differs from the flexible section 61 in that the rigid section 60 or the feed device 10 has a radial stability such that the cross-sectional diameter of the rigid section 60 is essentially unchangeable. The flexible section 61 allows an axial change in length and at the same time a radial change in diameter. The flexible section 61 or the receiving element 20 can therefore expand.

14b shows the device according to FIG 14a in the expanded state, the flexible section 61 or the receiving element 20 having a larger cross-sectional diameter than in the compressed state ( 14a ). The flexible section 61 or the receiving element 20 can be expanded by a suitable mechanism, for example a balloon can be arranged inside the receiving element 20 which is inflated or filled with a fluid to expand the receiving element 20 . The balloon may be fixedly connected to the containment member 20 or placed within the containment member 20 for expansion and then removed from the containment member 20 . For example, a fixed balloon may have a tuning fork-shaped longitudinal section that opens toward the distal end 26 of the containment member 20 . Furthermore, the balloon may comprise a plurality of expansion cushions, for example air cushions, which are arranged on the inner peripheral surface of the receiving element 20 . The rigid section 60 or the delivery device 10 can have several lumens or channels. Different channels can be provided for the function of inflating or filling the balloon or cushions and for the function of aspirating the thrombus.

• Kontrollierte Thrombenaspiration durch Einschränkung des Unterdruckbereiches. Der Unterdruck herrscht in einem geschlossenen Bereich zwischen proximalem Korb und Thrombus. Eine Gefäßkollabierung ist nicht möglich.

In summary, the invention offers the following advantages:

• Controlled thrombus aspiration by limiting the negative pressure range. The negative pressure prevails in a closed area between the proximal basket and the thrombus. A vascular collapse is not possible.

Defined aspiration volume: Only the volume that allows the thrombus to move into the basket is aspirated. No further volume of blood is withdrawn from the vessel.

Restriction of the risk of particle detachment: The negative pressure is generated when the blood is practically standing still. High blood velocities are not necessary, since no particles are removed from the thrombus by high shear stress.

Complete and 1-step thrombus aspiration: The invention does not result in the removal of thrombus particles, but in complete movement of the thrombus.

Reference List

10

feeding device

10a

tubular catheter

11

actuating device

13

pressure generating unit

14

actuating medium

14a

Fluid

14b

wire

15

pressure line

15a

proximal pressure line

15b

distal pressure line

16

common pressure generating unit

17

extracorporeal pump

17a

pressure membrane

17b

connection

17c

proximal pressure chamber

17d

distal pressure chamber

18

intracorporeal pump

18a

flexible shaft

20

receiving element

20a

proximal end section

21

proximal cover

22

cylindrical section

23

intake opening

24

funnel section

25

membrane

26

distal end

30a

proximal cavity

30b

distal cavity

31

chamber

32

receiving cavity

40

final element

41

distal cover

42a

proximal pressure port

42b

distal pressure port

43

attack

44

umbrella-like section

50

blood vessel

51

clot

52a, 52b

end stop

53a,b,c

sleeve of the end section

54

Feeder sleeve

55

Top

56

adapter

57

connector

57a

noses

58

counterpart

58a

recess

59

coil section

59a

holding section

60

rigid section

61

flexible section

Claims (26)

Device for removing calculus from body vessels with at least one compressible receiving element (20) for receiving calculus and a supply device (10) for guiding the compressed receiving element (20), wherein the receiving element (20) has a fluid-tight cover (21) which has a forms a cavity (30a) that can be closed by the concrement to be removed, in particular a proximal cavity (30a), wherein the receiving element (20) is assigned an actuating device (11) which, at least when in use, is in operative connection with the cover (21) and/or the cavity (30a). such that a different pressure can be set in the cavity (30a) for moving, in particular for loosening, the calculus to be removed than outside the cavity (30a) , characterized in that the actuating device (11) comprises a suction and/or pressure device, which is or can be fluidly connected to the cavity (30a) by a pressure line (15), the pressure line ( 15) is formed by the feed device (10) itself. device after claim 1 , characterized in that the actuating device (11) comprises an actuating medium (14), in particular a liquid, which can be pumped at least partially into the cavity (30a) and/or sucked out of the cavity (30a). device after claim 1 or 2 , characterized in that the receiving element (20) is designed like a basket and has a distal, essentially cylindrical section (22) which comprises a receiving opening (23) for receiving a calculus. Device according to one of Claims 1 until 3 , characterized in that the receiving element (20) has a proximal, essentially funnel-shaped section (24) which is connected to the actuating device (11), in particular the suction and/or pressure device. Device according to one of Claims 1 until 4 , characterized in that the cover (21) with the actuating device (11), in particular the pressure line (15), closes fluid-tight. Device according to one of Claims 1 until 5 , characterized in that the receiving element (20) is assigned a closing element (40), in particular a screen, which can be positioned distally to the calculus during use. device after claim 6 , characterized in that the closing element (40) has a fluid-tight cover (41) which is adapted to form a distal cavity (30b) in cooperation with at least the calculus to be removed. device after claim 6 or 7 , characterized in that the closing element (40) is fluidly connected to the pressure line (15), which is assigned to the receiving element (20), or to a further, separate pressure line in such a way that in the distal cavity (30b) for moving, in particular for loosening , the calculus a different pressure can be set than outside the distal cavity (30b). Device according to one of Claims 6 until 8th , characterized in that the closing element (40) and the receiving element (20) are fluidly connected to the actuating device (11), in particular the suction and/or pressure device, in such a way that between the distal cavity (30b) and the proximal cavity (30a ) for moving, in particular for loosening, the calculus arranged between the cavities (30a, 30b), different, in particular changeable, relative pressures can be set. Device according to one of Claims 6 until 9 , characterized in that the closing element (40) and the receiving element (20) are connected to a common pressure-generating unit (16). device after claim 10 , characterized in that the common pressure generating unit (16) is arranged extracorporeally and comprises at least one oscillating pressure membrane (17a) which is or can be fluidly connected to the closing element (40) and/or the receiving element (20) at least during use. device after claim 10 , characterized in that the common pressure generation unit (16) comprises a feed pump, in particular an intracorporeal feed pump (18), which is arranged within the pressure line (15) in such a way that the feed pump, at least when in use, communicates with the closure element (40) and/or is fluidly connected or fluidly connectable to the receiving element (20). Device according to one of Claims 10 until 12 characterized in that the pressure generation unit (13), in particular the common pressure generation unit (16), is assigned a control unit which is adapted in such a way that a pressure change in at least one, in particular both, cavities (30a, 30b) is frequency-dependent, in particular pulsating, in particular can be controlled in the form of a sine curve, in particular a sine amount curve. device after Claim 13 , characterized in that the control unit comprises at least one pressure measuring element which is connected to the suction and/or pressure device in such a way that the pressure which can be generated in the cavities (30a, 30b) can be measured and/or adjusted. Device according to one of Claims 1 until 14 , characterized in that the receiving element (20) comprises a flexible, fluid-tight membrane (25) which is operatively connected to at least one distal end (26) of the receiving element (20) on the one hand and to the actuating device (11) on the other hand. device after claim 15 , characterized in that the flexible membrane (25) with the cover (21) of the receiving element (20) forms a chamber (31) which is fluidly connected to that of the suction and/or pressure device, in particular the pressure line (15). that the pressure in the proximal cavity (30a) can be adjusted during use by the pressure in the chamber (31). Device for removing calculus from body vessels according to one of Claims 1 until 16 an end member (40) positionable distally of a calculus in use and comprising a fluid tight cover (41) adapted to form a distal cavity (30b) for cooperation with at least one calculus, said end member (40) having the suction and/or pressure device is operatively connected in such a way that a different pressure can be set in the distal cavity (30b) than outside the distal cavity (30b) for moving, in particular for loosening, the calculus. Device according to one of Claims 1 until 17 , characterized in that the receiving element (20) comprises a proximal end section (20a) which is essentially cylindrical and connected to the cavity (30a), the longitudinal axial extent of the end section (20a) being adapted such that the end section ( 20a) is at least partially arranged in the feed device (10) in use. device after Claim 18 , characterized in that the cylindrical section (22) and/or the funnel-shaped section (24) and/or the proximal end section (20a) comprise a braid. device after Claim 18 or 19 , characterized in that at least the cylindrical portion (22) comprises a cross-braid, in particular with axially arranged ribbons and at least the proximal end portion (20a) comprises a braid with spiral winding, in particular with axially arranged ribbons or an asymmetric braid. Device according to one of claims 18 until 20 , characterized in that the proximal end section (20a) and the supply device (10) each have an end stop (52a, 52b) such that an axial movement of the receiving element (20) in the distal direction can be limited. device after Claim 21 , characterized in that the end stop (52a) of the proximal end portion (20a) comprises at least one sleeve (53a) which is connected to the outer periphery of the proximal end portion (20a). device after Claim 22 , characterized in that the sleeve (53a) is connected to the proximal end section (20a) materially, positively, non-positively or by a further coaxially arranged sleeve (53b), the proximal end section (20a) between the two sleeves (53a, 53b ) is stuck. Device according to one of Claims 21 until 23 , characterized in that the end stop (52b) of the delivery device (10) comprises at least one sleeve (54) which is connected to the inner circumference of the delivery device (10) or a part of the distal tip (55) of the delivery device (10), the extends radially inward and has a smaller inner diameter than a proximal portion of the delivery device (10). Device according to one of Claims 1 until 24 , characterized in that the supply device (10) has an axially movable adapter (56) arranged in the supply device (10) which is connected to the receiving element (20), in particular to the proximal end section (20a) or the funnel-shaped section (24), is releasably connected in such a way that the receiving element (20) can be moved axially relative to the feed device (10). Device according to one of Claims 1 until 25 , characterized in that the receiving element (20), in particular the proximal end section (20a), is formed in one piece with the supply device (10), in particular with the actuating device (11) or with the suction and/or pressure device.

Images